Case research · Sources checked October 12, 2026
Suboxone (buprenorphine/naloxone) film dental injury products liability MDL
Plaintiffs allege that Suboxone film, a buprenorphine/naloxone product dissolved in the mouth to treat opioid use disorder, caused dental erosion and decay. ' Claims proceed under theories of failure to warn and design defect; on December 31, 2024 the court held in a lead case that post-approval design-defect and 'stop-selling' theories are preempted while a pre-approval design-defect claim and a failure-to-warn claim against Indivior Inc.
Every line on this page is checked against the court docket and the regulators involved. We do not decide whether you are part of this case or match you with a lawyer. What we do is help you get the medical records that matter, from any provider.
- Status
- Active
- Court
- U.S. District Court for the Northern District of Ohio (Eastern Division)
- Docket
- MDL No. 3092 (N.D. Ohio No. 1:24-md-03092-JPC)
- Judge
- Hon. J. Philip Calabrese
- Started
- February 2, 2024
- Defendants
- Indivior Inc., Indivior Solutions, Inc., Aquestive Therapeutics, Inc. (f/k/a MonoSol Rx)
Where it stands
As of October 12, 2026
As of the JPML's August 3, 2026 report, 1,827 actions were pending before Judge Calabrese. The litigation is in the bellwether work-up phase under the Second Amended Bellwether Protocol (CMO 15, March 27, 2026): a 500-plaintiff Record Collection Pool, a 50-case Core Discovery Pool whose deposition period runs July 13, 2026 to January 15, 2027, Trial Pool selection of 15 cases on January 29, 2027, and a proposed first bellwether trial setting in March 2028. CMO 23 (July 16, 2026) governs depositions of medical and dental providers for Core Discovery plaintiffs. No trial has occurred and no settlement appears in the posted orders.[5]
The complaint
What is alleged, and what is not decided
Plaintiffs allege that Suboxone film, a buprenorphine/naloxone product dissolved in the mouth to treat opioid use disorder, caused dental erosion and decay. In the JPML's words, 'Plaintiffs allege that defendants knew, but failed to warn, that Suboxone film causes damage to teeth.' Claims proceed under theories of failure to warn and design defect; on December 31, 2024 the court held in a lead case that post-approval design-defect and 'stop-selling' theories are preempted while a pre-approval design-defect claim and a failure-to-warn claim against Indivior Inc. survived the pleading stage. Nothing in the record establishes liability or causation.
On the record
What the regulators and the court have said
- 01
On January 12, 2022 FDA issued a Drug Safety Communication, 'FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain,' requiring a new warning about dental problems in the prescribing information and patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth. FDA identified 305 cases of dental problems, 131 classified as serious, in FAERS and the literature through December 31, 2018, and stated that 'the benefits of buprenorphine medicines clearly outweigh the risks.'[9]
- 02
FDA's patient advice in that communication: do not stop taking buprenorphine without talking to a health care professional; after the medicine dissolves, 'take a large sip of water, swish it gently around your teeth and gums, and swallow'; 'Wait at least 1 hour before brushing your teeth'; see a dentist soon after starting and tell the dentist you take buprenorphine.[9]
- 03
The current Suboxone sublingual film label (Indivior Inc., openFDA set 8a5edcf9-828c-4f97-b671-268ab13a8ecd, version 37, effective 2025-12-22) contains Warnings and Precautions section 5.13 'Dental Adverse Events': 'Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal buprenorphine-containing products. Reported events include cavities, tooth decay, dental abscesses/infection, rampant caries, tooth erosion, fillings falling out, and, in some cases, total tooth loss... Multiple cases were reported in individuals without any prior history of dental problems.' Postmarketing adverse reactions also list 'Dental decay (including caries, tooth fracture, and tooth loss).'[10]
- 04
The court's December 31, 2024 opinion states the Suboxone label 'did not warn of dental injuries until June 2022.'[4]
Timeline
How the case has moved
JPML centralizes 15 actions from five districts in the Northern District of Ohio before Judge J. Philip Calabrese and renames the litigation 'In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation'; 11 potential tag-along actions noted.[1]
Court denies Defendants' motion for phased discovery limited to general causation.[2]
Court dismisses without prejudice Defendants Indivior PLC, Reckitt Benckiser LLC and Reckitt Benckiser Healthcare (UK) Ltd.[2]
Amended CMO 3 permits direct filing in N.D. Ohio by 'any Plaintiff alleging dental injuries as a result of using Suboxone film,' for pretrial proceedings only, with presumptive transfer back to the designated Original Venue for trial.[3]
Opinion and Order on motion to dismiss (Bennett v. Indivior): pre-approval design-defect claim and failure-to-warn claim against Indivior Inc. survive; post-approval design defect and stop-selling theories held preempted; failure-to-warn dismissed as to Aquestive and Indivior Solutions.[4]
CMO 15 (Bellwether Protocol – Record Collection Pool) and CMO 14 (Joinder of Complaints) entered; Record Collection Pool later set at 500 randomly selected plaintiffs.[2]
Second Amended CMO 15 (Bellwether Protocol): 50-case Core Discovery Pool selected June 2026; depositions July 13, 2026–January 15, 2027; Trial Pool of 15 selected January 29, 2027; proposed first trial setting March 2028.[5]
CMO 23 sets procedures for deposing 'Any healthcare provider who has provided medical and/or dental care to a Core Discovery Plaintiff,' limited to four hours on the record.[7]
If this involves you
The records that matter, and who has them.
Whatever you decide to do next, you will be asked for these. They are yours by law, and most providers have up to 30 days to send them once they have your signed request.
Pharmacy fill history / PBM records for Suboxone film
the court's record-collection order exists to 'efficiently and timely obtain proof of Suboxone Film use'; product identification (film vs. tablet, brand vs. generic) is a defined dispute step in the bellwether protocol
Held by: pharmacy, PBM
Medication-assisted treatment (MAT) program / prescriber records
show prescribing dates, dose, counseling about oral hygiene, and whether buprenorphine was dissolved in the mouth; MAT programs are expressly named record custodians in Amended CMO 13
Held by: MAT clinic, addiction-medicine prescriber, OTP
Dental records, including charting, X-rays and treatment plans
document the dental condition before and after Suboxone use (caries, erosion, fractures, extractions, implants); the court's authorization covers a period starting five years before the first Suboxone prescription
Held by: general dentist, oral surgeon, dental school clinic
Dental insurance claims / EOBs
independent record of dental procedures and dates; insurance providers are named custodians in Amended CMO 13
Held by: dental insurer, Medicaid dental plan
Medical records (primary care, hospital)
document comorbidities and other medications that bear on dental health; providers may be deposed under CMO 23
Held by: primary care provider, hospital HIM department
We send the request, follow up with the provider, and deliver the records to you. We don't take case details here and we never share your records with a law firm unless you tell us to.
Questions people ask
Straight answers, with sources
Is the Suboxone tooth decay lawsuit real?
Yes. The JPML created MDL No. 3092 on February 2, 2024, centralizing federal cases alleging dental injury from Suboxone film in the Northern District of Ohio before Judge J. Philip Calabrese. As of the JPML's August 3, 2026 report, 1,827 actions were pending.[8]
Did the FDA actually warn about dental problems?
Yes. In a January 12, 2022 Drug Safety Communication FDA required a new dental-problems warning in the prescribing information and Medication Guide for buprenorphine medicines dissolved in the mouth, after identifying 305 reported cases (131 serious). The current Suboxone film label carries that warning in section 5.13.[9]
Has there been a trial or settlement?
Not according to the orders posted on the court's MDL 3092 page as of October 12, 2026. The Second Amended Bellwether Protocol (March 27, 2026) sets deposition and trial-pool selection dates through January 2027 and a proposed first trial setting in March 2028.[5]
Which companies are defendants?
The JPML order named Indivior Inc., Indivior Solutions Inc., Aquestive Therapeutics Inc., Reckitt Benckiser LLC and Reckitt Benckiser Healthcare (UK) Ltd. On September 10, 2024 the court dismissed Indivior PLC and the two Reckitt Benckiser entities without prejudice; Indivior Inc., Indivior Solutions and Aquestive remain.[2]
What records does the court collect in these cases?
Amended CMO 13 (March 31, 2026) directs healthcare providers, dental practices, pharmacies, PBMs, insurers and MAT programs to produce records on a court-approved authorization within 30 days, to obtain 'proof of Suboxone Film use, dental records, and other necessary records.'[6]
Should I stop taking Suboxone because of this?
FDA's safety communication says not to stop buprenorphine suddenly without first talking to a health care professional, and recommends rinsing with water after the film dissolves, waiting at least an hour before brushing, and seeing a dentist. This page is informational and is not medical advice.[9]
Sources
Where every fact on this page comes from
Primary sources only: court orders, the Judicial Panel on Multidistrict Litigation, federal regulators and state attorneys general. Each entry shows the day we opened it. This is reference material, not legal or medical advice.
- [1]MDL 3092 Transfer Order 1-24
JPML · jpml.uscourts.gov · opened October 12, 2026
February 2, 2024 order centralizing Suboxone film dental-injury actions in N.D. Ohio before Judge Calabrese.
- [2]MDL 3092 – In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
U.S. District Court, N.D. Ohio · ohnd.uscourts.gov · opened October 12, 2026
Index of all orders from February 2024 through July 16, 2026, including dismissals and bellwether orders.
- [3]Amended Case Management Order No. 3 (Direct Filing) (doc 165)
U.S. District Court, N.D. Ohio · ohnd.uscourts.gov · opened October 12, 2026
Permits direct filing of dental-injury cases in the MDL for pretrial proceedings only.
- [4]Opinion and Order granting in part and denying in part Defendants' motion to dismiss (12.31.2024)
U.S. District Court, N.D. Ohio · ohnd.uscourts.gov · opened October 12, 2026
Pre-approval design defect and failure-to-warn (Indivior Inc.) survive; post-approval design defect preempted; label did not warn of dental injury until June 2022.
- [5]Second Amended Case Management Order No. 15 (Bellwether Protocol) (Doc #668)
U.S. District Court, N.D. Ohio · ohnd.uscourts.gov · opened October 12, 2026
Record Collection Pool, Core Discovery Pool, Trial Pool structure and dates through a proposed March 2028 first trial.
- [6]Amended Case Management Order No. 13 (Collection of Records) (Doc #672)
U.S. District Court, N.D. Ohio · ohnd.uscourts.gov · opened October 12, 2026
Court-approved authorizations for medical, dental, pharmacy/MAT and insurance records; 30-day production.
- [7]Case Management Order No. 23 (Provider Depositions in Core Discovery Pool) (Doc #797)
U.S. District Court, N.D. Ohio · ohnd.uscourts.gov · opened October 12, 2026
Procedures for deposing medical and dental providers of Core Discovery plaintiffs.
- [8]Pending MDL Dockets By District – August 3, 2026
JPML · jpml.uscourts.gov · opened October 12, 2026
MDL 3092: Judge J. Philip Calabrese, 1,827 actions pending, 1,908 total.
- [9]FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
FDA · fda.gov · opened October 12, 2026
January 12, 2022 Drug Safety Communication requiring a dental-problems warning; 305 cases, 131 serious.
- [10]openFDA drug label — Suboxone sublingual film (Indivior Inc.), set 8a5edcf9-828c-4f97-b671-268ab13a8ecd
FDA (openFDA) · api.fda.gov · opened October 12, 2026
Version 37 (effective 2025-12-22) with Warnings and Precautions 5.13 Dental Adverse Events.